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Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Primary Purpose

Obesity, Overweight, Overnutrition

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intervention Program

About this trial

This is an interventional treatment trial for Obesity focused on measuring mHealth, Digital Health, Primary Care, Pragmatic Clinical Trial, Behavior Change, Weight Management

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients of Piedmont Health Services' community health centers in central North Carolina only
BMI between 25 and 40 kg/m2 and weighs less than 380 lbs
Speaks English or Spanish
Had a non-urgent outpatient visit at a participating community health center clinic at Piedmont Health Services within the last 2 weeks
Has a cell phone
Willing to receive 3-12 study-related text messages per week

Exclusion Criteria:

Current Piedmont Health Services employee
Has past bariatric surgery or planned bariatric surgery (within next 2 years)
Diagnosed with cancer in the last 6 months and is in active treatment
Has a history of cardiovascular event (stroke/MI) in the last 12 months
Was hospitalized for a mental health issue in the last 12 months
Diagnosis of end stage renal disease
Currently participating in a weight loss program/research study
Plans to move out of area and not receive care within community health center network (within the next 2 years)
Currently or recently pregnant (within the last 6 months) - Females only
Currently or recently lactating (with the last 2 months)- Females only
Plans to get pregnant in the next 12 months - Females only

Sites / Locations

Duke University - with Piedmont Health Services, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Program

Usual Care Program

Arm Description

Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers.

Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information.

Outcomes

Primary Outcome Measures

Change in weight

The proportion of intervention arm participants who achieve weight maintenance (staying within 3% of baseline weight in kg) at 24 months post-randomization. This will be calculated as follows: ((baseline weight in kg - final weight at 24 months in kg)/baseline weight in kg))x 100

Secondary Outcome Measures

Change in weight

Average change in participant weight at 24 months post randomization, as measured in kg

Change in blood pressure

Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg)

Change in Framingham risk score

Average change in participant Framingham risk score at 24 months post-randomization, as measured by calculated 10-year Framingham risk score from the Framingham Heart Study

Intervention cost-effectiveness

Assess the intervention's incremental cost at 24 months post-randomization, defined as the cost-effectiveness ratio of cost in dollars per kg of weight maintained at 24 mos, as compared to baseline weight in kg.

Full Information

NCT ID

NCT03003403

First Posted

December 16, 2016

Last Updated

May 8, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03003403

Brief Title

Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Official Title

Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical practice guidelines clearly recommend that these patients avoid gaining weight. However, despite this clinical guideline, weight gain prevention interventions are not available in primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for weight gain prevention for patients within rural community health centers, using a digital health platform.

Detailed Description

Clinical practice guidelines emphasize recommend weight gain prevention, but evidence-based treatments are not available in primary care. Balance, a pragmatic effectiveness trial, will test a scalable treatment approach for medically-vulnerable adults, those who suffer disproportionately from obesity and its adverse health effects. Balance builds on the design and findings of the Shape study (NCT00938535) to test a pragmatic intervention within rural community health centers. Balance will randomize overweight adults and adults with obesity who are patients a local community health center network (Piedmont Health Services) to either: 1) a 12-month weight gain prevention intervention or 2) usual care. Intervention group components include tailored behavior change goals; mHealth self-monitoring and feedback; skills training videos; and stepped responsive coaching from clinic Registered Dietitians. The usual care group will receive standard primary care offered by their providers and automated text messages and health information about maintaining a healthy weight. All intervention components and materials will be provided in Spanish or English.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight, Overnutrition, Nutrition Disorders, Signs and Symptoms

Keywords

mHealth, Digital Health, Primary Care, Pragmatic Clinical Trial, Behavior Change, Weight Management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

443 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Program

Arm Type

Experimental

Arm Description

Arm Title

Usual Care Program

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Intervention Program

Intervention Description

Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.

Primary Outcome Measure Information:

Title

Change in weight

Description

Time Frame

baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Secondary Outcome Measure Information:

Title

Change in weight

Description

Average change in participant weight at 24 months post randomization, as measured in kg

Time Frame

Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Title

Change in blood pressure

Description

Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg)

Time Frame

baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Title

Change in Framingham risk score

Description

Average change in participant Framingham risk score at 24 months post-randomization, as measured by calculated 10-year Framingham risk score from the Framingham Heart Study

Time Frame

baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Title

Intervention cost-effectiveness

Description

Time Frame

24 months post-randomization (up to 27 months to obtain 24 month data)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of Piedmont Health Services' community health centers in central North Carolina only BMI between 25 and 40 kg/m2 and weighs less than 380 lbs Speaks English or Spanish Had a non-urgent outpatient visit at a participating community health center clinic at Piedmont Health Services within the last 2 weeks Has a cell phone Willing to receive 3-12 study-related text messages per week Exclusion Criteria: Current Piedmont Health Services employee Has past bariatric surgery or planned bariatric surgery (within next 2 years) Diagnosed with cancer in the last 6 months and is in active treatment Has a history of cardiovascular event (stroke/MI) in the last 12 months Was hospitalized for a mental health issue in the last 12 months Diagnosis of end stage renal disease Currently participating in a weight loss program/research study Plans to move out of area and not receive care within community health center network (within the next 2 years) Currently or recently pregnant (within the last 6 months) - Females only Currently or recently lactating (with the last 2 months)- Females only Plans to get pregnant in the next 12 months - Females only

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary G Bennett, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dori M Steinberg, PhD, RD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University - with Piedmont Health Services, Inc.

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27708

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31101037

Citation

Berger MB, Steinberg DM, Askew S, Gallis JA, Treadway CC, Egger JR, Kay MC, Batch BC, Finkelstein EA, DeVries A, Brewer A, Bennett GG. The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. BMC Public Health. 2019 May 17;19(1):596. doi: 10.1186/s12889-019-6926-7.

Results Reference

derived

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Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

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